# K052663: Ino Therapeutics Inoblender, Model 10004

- Pathway: 510(k) (Special)
- Applicant: Ino Therapeutics
- Decided: Nov 4, 2005 after 38 days
- Product code: MRO (Apparatus, Nitric Oxide, Backup Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003665 (2001). 2 ancestors in all.
26 later devices descend from it; 2 cite it directly.
5 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011874: Fadasis Medical FM-1 NO Blender, Fadasis Medical, Inc. (2001). Our reading of the summary gave K001874, FDA’s number for Peripherally Inserted Central Catheter (Utah Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FM-I NO Blender”. Summary page 1.
- K003665: Fadassi Medical FM-1 NO Blender, Fadasis Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003 (2006), 24 descendants of its own
- K092545: Inomax DS (Delivery System), Model 10003 (2010), 16 descendants of its own
- K070867: Inomax DS (Delivery System), Model 10003 (2007), 15 descendants of its own
- K071516: Inomax DS (2007), 14 descendants of its own
- K093922: Inomax DS (2010), 11 descendants of its own

## Indications for use
The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

Source page: https://510kreport.com/device/K052663
Methodology: https://510kreport.com/methodology